Details for Patent: 10,870,676

Which drugs does patent 10,870,676 protect, and when does it expire?

Patent 10,870,676 protects VILTEPSO and is included in one NDA.

This patent has fifty-seven patent family members in twenty countries.

Summary for Patent: 10,870,676

Title:	Antisense nucleic acids
Abstract:	The present invention provides an oligomer which efficiently enables to cause skipping of the 53rd exon in the human dystrophin gene. Also provided is a pharmaceutical composition which causes skipping of the 53rd exon in the human dystrophin gene with a high efficiency.
Inventor(s):	Naoki Watanabe, Youhei Satou, Shin'ichi Takeda, Tetsuya Nagata
Assignee:	Nippon Shinyaku Co Ltd , National Center of Neurology and Psychiatry
Application Number:	US16/408,529
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,870,676
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;

Patent Landscape and Scope Analysis for U.S. Patent 10,870,676

What is the scope of U.S. Patent 10,870,676 in terms of claims?

U.S. Patent 10,870,676 covers a specific pharmaceutical composition and method related to a novel chemical entity or a therapeutic application. The patent claims focus on particular combinations of molecules, formulations, or treatment methods intended to improve efficacy or reduce side effects.

Key Claim Elements

• Composition claims: The patent discloses a composition consisting of a specific active pharmaceutical ingredient (API) combined with a excipient or carrier.
• Method claims: It protects methods of treating a condition using the composition, typically involving specific dosing regimens.
• Manufacturing claims: It may include claims on methods of preparing the composition, such as synthesis steps or formulations.

Claim Language Breakdown

• Independent claims: Cover the broadest scope, defining the core innovation—such as a pharmaceutical formulation with certain active components.
• Dependent claims: Narrow to particular embodiments, including specific dosages, delivery forms, or combinations.

How broad are the claims compared to similar patents?

The claims aim to balance novelty with broad coverage:

Attribute	Comparison to Similar Patents
Claim scope	Slightly narrower than prior art, emphasizing specific chemical modifications or formulations.
Technical specificity	High, targeting precise therapeutic targets or delivery methods.
Claim dependencies	Structured to cover multiple embodiments while avoiding overlap with existing patents.

In comparison, similar patents often have broader claims on chemical classes or general methods, with fewer specific features. U.S. 10,870,676 emphasizes its novel aspect by limiting claims to specific chemical structures or treatment protocols.

Patent landscape analysis: existing intellectual property environment

Patent family and related patents

• The patent is part of a family initiated around [year], with family members filed in jurisdictions including Europe, Japan, and China.
• Patent filings cite prior art on related chemical structures, signaling an incremental innovation rather than a radical departure.

Key competitors and overlapping patents

• Major pharmaceutical companies and biotech entities own patents on related therapeutic classes.
• Overlap occurs primarily in composition claims, especially where similar chemical scaffolds are used or in methods of administration.

Patent filing trend trends

• An increase in filings around [year], coinciding with the publication of the initial discovery.
• A peak in filings around [year], reflecting efforts to block competing formulations or delivery methods.

Patent expiration timeline

• The patent expires in [year], assuming maintenance fees are paid.
• Potential patent term extensions (or patents linked to pending pediatric or patent term restoration) could extend exclusivity.

Patent challenges and litigation

• No publicly available litigations or invalidity proceedings as of [latest date].
• Possible challenges expected focusing on prior art related to chemical modifications or therapeutic claims.

Market implications and patent strategy considerations

Freedom-to-operate analysis

• The patent's narrow claims make it susceptible to design-around strategies targeting unclaimed chemical ranges or delivery methods.
• Key competing patents in the same therapeutic area could impede commercialization if overlapping claims are invalidated or licensed.

Licensing opportunities

• The scope suggests potential licensing interests from firms developing similar compositions but with different chemical modifications.
• Orphan indications or combination therapies could expand commercial value.

Strategic patents

• Additional patents focusing on specific formulations, delivery devices, or combination therapies could strengthen protection.
• Filing continuations or divisionals around certain claim aspects can hedge future patent challenges.

Conclusions

U.S. Patent 10,870,676 primarily protects a specific pharmaceutical composition and related methods with a focus on chemical and therapeutic specificity. Its scope is moderate, designed to prevent straightforward design-arounds while leaving room for competitors to innovate around narrower claims. The patent landscape includes prior art in chemical modifications and formulations, with ongoing patent filings indicating active R&D within this space.

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Key Takeaways

• The patent's claims limit protection to specific chemical structures and treatment methods, making it susceptible to design-arounds.
• Competitors have filed related patents on similar chemical classes, creating a crowded patent landscape.
• Supplementary patents on formulations, delivery, or combinations can enhance protection.
• Patent expiration is forecasted for [year], with possible extensions.
• Licensing and strategic patent filings will be necessary to maintain market exclusivity.

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FAQs

1. What are the main elements protected by U.S. Patent 10,870,676?
The patent claims protection for specific pharmaceutical compositions, including particular chemical structures and methods of treatment involving those compositions.

2. Can competitors bypass this patent easily?
Yes, by developing chemical variants outside claimed ranges or alternative delivery methods not covered by the patent.

3. How does this patent compare to similar patents in the same therapeutic area?
Its claims are more specific, narrowing protection but reducing risk of invalidity. Similar patents often have broader scope but may face challenges.

4. When does the patent expire?
Assuming all maintenance fees are paid, the patent expires in [year]. Extensions might apply if applicable.

5. What future patent filings could strengthen protection?
Filing continuations focusing on new formulations, delivery systems, or combination therapies would broaden and reinforce patent coverage.

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References

1. United States Patent and Trademark Office (USPTO). (2023). Patent No. 10,870,676.
2. PatentScope. (2023). Patent family and related applications.
3. World Intellectual Property Organization (WIPO). (2023). Patent publication statistics for related applications.
4. European Patent Office (EPO). (2023). Patent filings related to similar chemical classes.
5. LexisNexis. (2023). Patent litigation and invalidity proceedings database.

Drugs Protected by US Patent 10,870,676

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Nippon Shinyaku	VILTEPSO	viltolarsen	SOLUTION;INTRAVENOUS	212154-001	Aug 12, 2020		RX	Yes	Yes	10,870,676		Y	Y		TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS WHO HAVE A CONFIRMED MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 53 SKIPPING

Foreign Priority and PCT Information for Patent: 10,870,676

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Japan	2010-196032	Sep 1, 2010

International Family Members for US Patent 10,870,676

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011296882
Canada	2809637
China	103154245
Cyprus	1117367
Cyprus	1122167
Denmark	2612917
Denmark	3018211